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A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.

Primary Purpose

Generalized Anxiety Disorder

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg
Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg
placebo
Sponsored by
Luye Pharma Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Toludesvenlafaxine Hydrochloride Sustained-release Tablet, generalized anxiety disorder, efficacy, safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female aged 18 to 65 years subjects; Meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for Generalized Anxiety Disorder; Have a Hamilton Anxiety(HAMA) Rating Scale total score ≥21 points at screening and baseline; Have a Hamilton Anxiety(HAMA) Rating Scale score ≥2 points on both item 1(anxious mood) and item 2(tension) at screening and baseline; Have a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening and baseline. Exclusion Criteria: Meet the diagnostic criteria for other psychotic disorders(defined by DSM-5, except for GAD), including major depression disorder within 6 months prior to screening , presence or history of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Obsessive-Compulsive and related Disorders, post-traumatic stress disorder, anorexia nervosa or bulimia and personality disorder; Meet the diagnostic criteria for substance or alcohol abuse (defined by DSM-5, except for nicotine or caffeine) within 6 months prior to screening; Have anxious symtoms secondary to other physical illnesses or mental illnesses and anxious induced by psychoactive substance; Withdrawal psychotropic drugs within 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors, at least 1 month for fluoxetine, and at least 2 weeks for benzodiazepines or barbiturates) prior to randomization; Have received psychosurgery or physical therapy for psychiatric illness (such as transcranial magnetic stimulation) within 3 months prior to screening; Have received systematic psychotherapy or other non-drug therapies for psychiatric disorders (such as acupuncture or light therapy) within 6 weeks prior to screening; Concomitant with serious and unstable illness, including cardiovascular, hepatic, renal, hematological, endocrine illness, malignant tumors and other physical illness; Have a history of seizures (except for seizures caused by febrile convulsions in childhood); Have a history of gastrointestinal disease or surgery known to interfere with investigation product absorption or excretion; Known or suspected allergic or severe reaction to investigation product or inactive ingredients; or allergic to venlafaxine or desvenlafaxine; or allergic constitution (defined as allergic to two or more drugs or food) and unfit to participate judged by investigator;

Sites / Locations

  • Peking University Sixth Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group

Placebo

Arm Description

orally once a day

orally once a day

orally once a day

Outcomes

Primary Outcome Measures

Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint
The HAMA Scale consist of 14 items that include psychic, somatic, and behavioral symptoms associated with anxiety. Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 56, with high scores indicating greater illness severity.

Secondary Outcome Measures

Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale psychic factor score (Items 1~6 and Item 14) at endpoint
The psychic factor score is the sum of items 1-6 and items 14(including items such as anxious mood, tension, fear, insomnia, and behavioral symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint
The somatic factor score is the sum of items 7-13(including items such as cardiovascular, respiratory, and gastrointestinal symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1(Anxious mood)Score at endpoint
The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2(Tension)Score at endpoint
The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.
Percentage of participants with response at endpoint
Response was defined as a≥50% reduction from baseline to endpoint in the HAMA total score.
Percentage of participants with remission at endpoint
Remission was defined as a HAMA total score ≤7 points at endpoint
Clinical Global Impression Scale - improvement (CGI-I) score at endpoint
The CGI-I scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint
The CGI-S scale is a 7-point scale to rate the severity of the patient's illness. Patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint
The SDS scale consists of 3 items evaluating impairment in work/school, social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint
The scale consists of 3 items evaluating impairment in work/school, social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).
Incidence and severity of adverse effects (AEs)
Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint
The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.

Full Information

First Posted
July 24, 2023
Last Updated
August 1, 2023
Sponsor
Luye Pharma Group Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05970510
Brief Title
A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Participants With Generalized Anxiety Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2023 (Anticipated)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luye Pharma Group Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets compared to placebo in adults participants with generalized anxiety disorder over a period of 8 weeks.
Detailed Description
The study consists of two periods: screening period (2 weeks) and double-blind treatment period (8 weeks). After the screening period, generalized anxiety disorder patients who satisfies the inclusion criteria are randomly assigned in the 1:1:1 ratio to receive either placebo or Toludesvenlafaxine Hydrochloride Sustained-release Tablets at two dose levels (80 ,160 mg/day) for 8 weeks. Participants are evaluated at screening, baseline visits and double-blind period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Toludesvenlafaxine Hydrochloride Sustained-release Tablet, generalized anxiety disorder, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
555 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group
Arm Type
Experimental
Arm Description
orally once a day
Arm Title
Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group
Arm Type
Experimental
Arm Description
orally once a day
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
orally once a day
Intervention Type
Drug
Intervention Name(s)
Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg
Intervention Description
orally once a day
Intervention Type
Drug
Intervention Name(s)
Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg
Intervention Description
orally once a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
orally once a day
Primary Outcome Measure Information:
Title
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint
Description
The HAMA Scale consist of 14 items that include psychic, somatic, and behavioral symptoms associated with anxiety. Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 56, with high scores indicating greater illness severity.
Time Frame
from baseline to week 8
Secondary Outcome Measure Information:
Title
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale psychic factor score (Items 1~6 and Item 14) at endpoint
Description
The psychic factor score is the sum of items 1-6 and items 14(including items such as anxious mood, tension, fear, insomnia, and behavioral symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.
Time Frame
from baseline to week 8
Title
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint
Description
The somatic factor score is the sum of items 7-13(including items such as cardiovascular, respiratory, and gastrointestinal symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.
Time Frame
from baseline to week 8
Title
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1(Anxious mood)Score at endpoint
Description
The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.
Time Frame
from baseline to week 8
Title
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2(Tension)Score at endpoint
Description
The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.
Time Frame
from baseline to week 8
Title
Percentage of participants with response at endpoint
Description
Response was defined as a≥50% reduction from baseline to endpoint in the HAMA total score.
Time Frame
from baseline to week 8
Title
Percentage of participants with remission at endpoint
Description
Remission was defined as a HAMA total score ≤7 points at endpoint
Time Frame
from baseline to week 8
Title
Clinical Global Impression Scale - improvement (CGI-I) score at endpoint
Description
The CGI-I scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time Frame
from baseline to week 8
Title
Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint
Description
The CGI-S scale is a 7-point scale to rate the severity of the patient's illness. Patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Time Frame
from baseline to week 8
Title
Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint
Description
The SDS scale consists of 3 items evaluating impairment in work/school, social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).
Time Frame
from baseline to week 8
Title
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint
Description
The scale consists of 3 items evaluating impairment in work/school, social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).
Time Frame
from baseline to week 8
Title
Incidence and severity of adverse effects (AEs)
Time Frame
from baseline to week 8
Title
Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint
Description
The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Time Frame
from baseline to week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 to 65 years subjects; Meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for Generalized Anxiety Disorder; Have a Hamilton Anxiety(HAMA) Rating Scale total score ≥21 points at screening and baseline; Have a Hamilton Anxiety(HAMA) Rating Scale score ≥2 points on both item 1(anxious mood) and item 2(tension) at screening and baseline; Have a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening and baseline. Exclusion Criteria: Meet the diagnostic criteria for other psychotic disorders(defined by DSM-5, except for GAD), including major depression disorder within 6 months prior to screening , presence or history of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Obsessive-Compulsive and related Disorders, post-traumatic stress disorder, anorexia nervosa or bulimia and personality disorder; Meet the diagnostic criteria for substance or alcohol abuse (defined by DSM-5, except for nicotine or caffeine) within 6 months prior to screening; Have anxious symtoms secondary to other physical illnesses or mental illnesses and anxious induced by psychoactive substance; Withdrawal psychotropic drugs within 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors, at least 1 month for fluoxetine, and at least 2 weeks for benzodiazepines or barbiturates) prior to randomization; Have received psychosurgery or physical therapy for psychiatric illness (such as transcranial magnetic stimulation) within 3 months prior to screening; Have received systematic psychotherapy or other non-drug therapies for psychiatric disorders (such as acupuncture or light therapy) within 6 weeks prior to screening; Concomitant with serious and unstable illness, including cardiovascular, hepatic, renal, hematological, endocrine illness, malignant tumors and other physical illness; Have a history of seizures (except for seizures caused by febrile convulsions in childhood); Have a history of gastrointestinal disease or surgery known to interfere with investigation product absorption or excretion; Known or suspected allergic or severe reaction to investigation product or inactive ingredients; or allergic to venlafaxine or desvenlafaxine; or allergic constitution (defined as allergic to two or more drugs or food) and unfit to participate judged by investigator;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Hongyan
Phone
13601237138
Email
hongyanzhang@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Hongyan
Organizational Affiliation
Peking University Sixth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Sixth Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.

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